UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of long-term anti-IgE antibody therapy in the patients with wheat allergy
Acronym	Long-term anti-IgE antibody therapy
Scientific Title	Evaluation of long-term anti-IgE antibody therapy in the patients with wheat allergy
Scientific Title:Acronym	Long-term anti-IgE antibody therapy
Region	Japan

Condition
Condition	Wheat allergy
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the therapeutic efficacy of anti-IgE antibody long-term therapy in the patients with severe wheat allergy, by patient's clinical condition and basophil activation test using peripheral blood.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of reactivity below 10% to wheat allergen in basophil activation test using peripheral blood after the treatment.
Key secondary outcomes	Rate of 0 score in wheat-challenge test after the treatment.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1. Generic name: Omalizumab; trade name: Xolair for s.c. ingection 75mg/V or 150mg/V (Novartis Pharma, Japan). 2. Start the treatment protocol within 4 weeks of entry. Administration dose and intervals of Omalizumab are calculated by total IgE and body weight, 75-600mg for 2-4 week interval. Duration of administrations is 44 weeks and follow-up is 24 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. More than 20 years old male and female. 2. Patients who meet the diagnostic criteria of immediate-type wheat allergy induced by GP19S made by Special Committee for Japanese Society for Allergology; Patient who meet the diagnostic criteria of wheat-dependent exercise-induced anaphylaxis made by study group of Guideline for the treatment of life-threatening food allergy, supported by Health and Labor Sciences Research Grant; Patients who had an allergic reaction to wheat within one year or patients who avoid wheat ingestion because of the high titer of serum wheat-specific IgE. 3. Those who can visit doctor's office every 2 to 4 weeks. 4. Those who can sign the treatment consent form.
Key exclusion criteria	1. Patients who have hypersensitivity to ingredients of Omalizumab (Novartis Pharma, Japan). 2. Patients who receive immunosuppressive drugs. 3. Patients with decompensated liver cirrhosis. 4. Patients with severe kidney disease; more than 2.0mg/dL of serum creatinine level within 4 weeks prior to the entry. 5. Patients with liver disease, psychiatric disorder, convulsive seizure and seizure disorder, cardiovascular disease, abnormal hemoglobin disease, hemophilia, and autoimmune disease. 6. Pregnant women, breast-feeding women, and women suspected of being pregnant. 7. Patients ineligible for the clinical trial at a physician's discretion.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Eishin Middle name Last name Morita
Organization	Shimane University Hospital
Division name	Dermatology
Zip code	6938501
Address	Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL	0853-20-2210
Email	emorita@med.shimane-u.ac.jp

Public contact
1st name of contact person	1st name Yuko Middle name Last name Chinuki
Organization	Shimane University Hospital
Division name	Dermatology
Zip code	6938501
Address	Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL	0853-20-2210
Homepage URL	http://www.rcplrd.org/clinical_research
Email	ychinuki@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Hospital
Institute
Department

Funding Source
Organization	Research center for prevention of lifestyle-related disease
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Fujita Health University National Hospital Organization, Sagamihara National Hospital National Hospital Organization, Fukuoka National Hospital Tokyo Medical and Dental University Osaka University Hiroshima University Hyogo Prefectural Kakogawa Medical Center Kobe University
Name of secondary funder(s)	Yuuka Co., Ltd Katayama Kogyo Co., Ltd PHOENIX Co., Ltd

IRB Contact (For public release)
Organization	Clinical Resarch Center, Shimane University Hospital
Address	89-1, Enya-cyou, Izumo, Shimane
Tel	0853-20-2515
Email	kenkyu@med.shimane-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

島根大学（島根県）Shimane University (Shimane) 藤田保健衛生大学（愛知県）Fujita Health University (Aichi) 東京医科歯科大学（東京都）Tokyo Medical and Dental University (Tokyo) 大阪大学（大阪府）Osaka University (Osaka) 広島大学（広島県）Hiroshima University (Hiroshima) 神戸大学（兵庫県）Kobe University (Hyogo) 兵庫県立加古川医療センター（兵庫県）Hyogo Prefectural Kakogawa Medical Center (Hyogo) 国立病院機構相模原病院（神奈川県）National Hospital Organization, Sagamihara National Hospital (Kanagawa) 国立病院機構福岡病院（福岡県）National Hospital Organization, Fukuoka National Hospital (Fukuoka)

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 28 Day
Date of IRB	2015 Year 09 Month 28 Day
Anticipated trial start date	2015 Year 09 Month 28 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 06 Day
Last modified on	2019 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022254